Recall of Allergan BIOCELL textured Implants
Allergan has made a decision, in conjunction with FDA, to recall all Allergan implants that are textured with BioCell texturing. This type of texturing may be linked to a rare disease called Breast Implant Associated anaplastic large cell lymphoma (BIA-ALCL). Allergan is doing this voluntarily, while this issue is investigated further.
At this time, there is no recommendation to remove implants already in place, but there will be a hold on implanting any more of these implants. This does not affect Allergan’s SMOOTH implants, only the BioCell textured types.
Patients are urged to contact their plastic surgeon about the risks or benefits of their specific implants. There is a table below that references the specific implants that are being recalled. So far, there has been no recall of textured devices from other manufacturers in the United States. And this recall does not affect the range of Allergan’s smooth implant lineup.
As always in our practice, patient safety is our highest priority. This information is being posted for your information and reference. This information is accurate as of July 24, 2019. We will continue to be watchful as this issue develops. It is our opinion that smooth breast implants continue to be safe, and the best studies support this opinion. We will also continue to offer textured implants from other manufacturers for those that desire them, since the information about non-BIOCELL textured implants also continues to show a very good safety profile.
You can reference the press release below:
07.24.2019 | Investors
Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
— Global Action Follows Notification of Updated Safety Information from the U.S. Food and Drug Administration (FDA) —
— FDA Does Not Recommend Removal or Replacement of Textured Breast Implants in Asymptomatic Patients —
— Smooth and MICROCELL® Breast Implants and Tissue Expanders Not Impacted —
DUBLIN, July 24, 2019 /PRNewswire/ — Allergan plc (NYSE: AGN) today announced a voluntary worldwide recall of BIOCELL® textured breast implants and tissue expanders. Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA).
BIOCELL® saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available. Effective immediately, healthcare providers should no longer implant new BIOCELL® textured breast implants and tissue expanders and unused products should be returned to Allergan. Allergan will provide additional information to customers about how to return unused products.
Patient safety is a priority for Allergan. Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns.
Importantly, the FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients.
This global recall does not affect Allergan’s NATRELLE® smooth or MICROCELL® breast implants and tissue expanders.
The recalled products include:
|Natrelle Saline breast implant styles 168, 363, 468|
|Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX|
|Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX|
|Natrelle 510 Dual-Gel styles LX, MX, FX|
|Natrelle INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX|
|Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch|
|Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM|
|Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM|
|Natrelle 150 Full Height and Short Height double lumen implants|
Natrelle 133 tissue
expanders with and without suture tabs: styles 133FV, 133MV, 133LV,
133MX, 133SX, 133SV, T-133FV, |
T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T
Natrelle 133 Plus
tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, |
133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T
U.S. healthcare providers with questions regarding this announcement can contact Medical Information at 1-800-678-1605 option #2 or IR-Medcom@allergan.com. For all other countries, please use the contact details at the following link on Allergan’s website: Allergan Global Medical Information Contacts.
Adverse events or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: download form www.fda.gov/MedWatch/getforms.htm or call 1-800-FDA-1088 to request form, then complete and return address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.